MAUDE Adverse Event Report: SKELETAL DYNAMICS SKELETAL DYNAMICS; ALIGN RADIAL HEAD SYSTEM

Model Number	ALIGN Radial Head & Lock Screw, 24mm
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Implant Pain (4561)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has indicated that the product will be returned to us for investigation, but it has not been returned yet.The investigation is in process, however, no additional information has been provided at the time of filing this report.The instruction for use state: the lock screw packaged with the radial head must be installed and fully tightened to fix the radial head to the radial stem.If the lock screw is not attached and/or fully secured, the radial head may loosen and/or disconnect from the radial stem, causing soft tissue irritation and/or device failure.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 2 years post implantation due to loosening of the product.The screw had backed out from the radial head causing it to become loose.The head and screw were replaced onto the existing stem.Attempts have been made for additional information and/or the explanted product to be returned but is unavailable at this time of filing the report.

• Brand Name: SKELETAL DYNAMICS
• Common Device Name: ALIGN RADIAL HEAD SYSTEM
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n. kendall drive; suite 400; miami FL 33156
• MDR Report Key: 11517590
• Report Number: 3006742481-2021-00003
• Device Sequence Number: 4140419
• Product Code: KWI
• UDI-Device Identifier: 00841506100043
• UDI-Public: 00841506100043
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ALIGN Radial Head & Lock Screw, 24mm
• Device Catalogue Number: ALN-RHI-240
• Device Lot Number: AN1806008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 73